Trial purpose
Cancer treatment
Tumor type
Haematological
Age
<17
Clinical summary
Summary
This is a randomised, open-label trial with two arms. Participants in Arm A will receive Backbone ALL R3. Participants in Arm B will receive Backbone ALL Re + Bortezomib. Bortezomib will be administered at 1.3mg/m2 as intravenous bolus or subcutaneously on days 1 and 4 of weeks 1 and 3.
Conditions
This trial is treating people with acute lymphoblastic leukaemia
Eligibility
Inclusion
- Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL
- Children less than 18 years of age at date of inclusion into the study
- Meeting HR criteria any BM relapse, early/very early isolated BM relapse, very early isolated/combined extramedullary relapse)
- Patient enrolled in a participating centre
- Written informed consent
- Start of treatment falling into the study period
- No participation in other clinical trials 30 day prior to study enrolment that interfere with this protocol, except trials for primary ALL
Exclusion
- Breakpoint cluster region-Abelson (BCR-ABL)/ t(9;22) positive ALL
- Pregnancy or positive pregnancy test (urine sample positive for β-humane choriongonadotropin (HCG) > 10 U/l)
- Sexually active adolescents not willing to use highly effective contraceptive method (pearl index <1) until 12 months after end of anti-leukemic therapy
- Breast feeding
- Relapse post allogeneic stem-cell transplantation
- Neuropathy > II°
- The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian
- Objection to the study participation by a minor patient, able to object
- Any patient being dependent on the investigator
- No consent is given for saving and propagation of pseudonymized medical data for study reasons
- Severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)
- Subjects unwilling or unable to comply with the study procedures
- Subjects who are legally detained in an official institute
Exclusion
- You have certain types of non-cancer medical conditions.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Charite University, Berlin, Germany,Australian and New Zealand Children's Haematology and Oncology Group (ANZCHOG)
Scientific Title
International Study for Treatment of High Risk Childhood Relapsed ALL 2010 A Randomized Phase II Study Conducted by the Resistant Disease Committee of the International Berlin, Frankfurt, Münster (BFM) Study Group
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information